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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

India's Clinical Trials Attract Patients, Scrutiny

Global pharmaceutical manufacturers have been flocking to India since 2005 when guidelines restricting clinical trials were eased.&nbsp; The result: roughly 150,000 Indians participated in clinical trials in 2011-a phenomenal rise given that the country had almost no patients enrolled as of 2004.

Roughly 1,700 participants in clinical trials died between 2007 and 2010, though the cause of death was not necessarily attributable to the pharmaceutical product being received. While some of the families have received compensation for the loss of family members, monies paid out as compensation pales in comparison to the overall revenues generated to the Indian economy-some $300 million in 2010 alone.

Ethical lapses, including uninformed consent, lack of compensation for victims of injury suffered as a result of the trials, falsification of records, and improper payments to doctors to enroll patients are causing blow-back from activists and patients alike.&nbsp; One medical journal editor referred to Indian patients as "guinea pigs" when describing their treatment.

The US Food and Drug Administration is apparently investigating some of the claims made by Indian activists against western pharmaceutical companies, and the Indian Council for Medical Research has proposed draft guidelines for compensating victims of clinical-trial-related injuries.